Ozobax - baclofen oral solution
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What is OZOBAX®?

  • OZOBAX is the first FDA-approved oral liquid baclofen.1
  • OZOBAX is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus and muscular rigidity.2
  • OZOBAX may also be of some value in patients with spinal cord injuries and other spinal cord diseases.2
  • OZOBAX is not approved for use in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
  • OZOBAX contains 5 mg/5 mL baclofen. It is a clear, colorless solution with a pleasant grape aroma. OZOBAX must be kept refrigerated at 36ºF to 46ºF.

Limitations of Use: OZOBAX is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

What is baclofen?3

Baclofen is a skeletal muscle relaxant used to treat some types of spasticity associated with certain disorders along with associated pain, clonus, and muscular rigidity. Oral baclofen comes in two formulations: oral tablets, and oral liquid.

How OZOBAX works4

OZOBAX can block nerve impulses both before a signal is sent and on the receiving end of the signal transmission at neuromuscular junctions close to the spine. As a result, OZOBAX essentially decreases the readiness of a nerve cell or neural circuit to respond to a stimulus, leading to decreasing input to muscle fibers.

Efficacy of OZOBAX

  • For OZOBAX, the peak plasma concentrations are achieved in about 45 minutes.5
  • In Multiple Sclerosis, oral baclofen demonstrated significantly better efficacy than placebo at improving muscle tone. 55%-72% of patients experienced an improvement with baclofen compared with the 0%-17.4% of patients who were given placebo.6
  • Other studies in MS patients also demonstrated better efficacy in reducing spasm frequency with baclofen (42%-72%) than with placebo (6.3%-16%).6

 

References:

  1. U.S. Food & Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed January 9, 2020.
  2. OZOBAX [prescribing information]. Athens, GA: Metacel Pharmaceuticals, LLC; 2019.
  3. BACLOFEN- baclofen tablet. Prescribing Information. Teva Pharmaceuticals USA, Inc. Revised: 12/2019. https://www.tevagenerics.com/product/baclofen-tablets-usp. Accessed Feb. 12, 2020
  4. Chang E., A Review of Spasticity Treatments: Pharmacological and Interventional Approaches. Crib Rev Phys RehabilMed. 2013; 25(1-2): 11–22. doi:10.1615/CritRevPhysRehabilMed.2013007945.
  5. OZOBAX (baclofen) oral solution Prescribing Information. Revised 09/2019. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208193s000lbl.pdf. Accessed Feb. 13, 2020.
  6. ERTZGAARD P, CAMPO C and CALABRESE A. EFFICACY AND SAFETY OF ORAL BACLOFEN IN THE MANAGEMENT OF SPASTICITY: A RATIONALE FOR INTRATHECAL BACLOFEN. J Rehabil Med 2017; 49: 193–203.

Important Safety Information

OZOBAX® is contraindicated in patients with hypersensitivity to baclofen.

Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when OZOBAX is discontinued.

Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue OZOBAX before delivery.

OZOBAX can cause drowsiness and sedation. Patients should avoid the operation of machinery until they know how the drug affects them. Advise patients that the central nervous system effects of OZOBAX may be additive to those of alcohol and other CNS depressants.

OZOBAX should be used with caution in patients who have had a stroke.

OZOBAX can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions.

The most common adverse reactions (>1%) in patients treated with baclofen for spasticity are drowsiness, dizziness, weakness, nausea, confusion, hypotension, headache, insomnia, constipation, urinary frequency and fatigue.

You are encouraged to report adverse reactions to Metacel Pharmaceuticals, LLC at 1-833-469-6229 or to the FDA:  www.fda.gov/medwatch or 1-800-FDA-1088.

Please see the accompanying Full Prescribing Information.